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The effect of return of Del-Nido cardioplegia solution to the extra-corporeal circulation circuit on serum osmolarity variations and clinical outcomes in pediatrics undergoing congenital cardiac defects surgery

Protocol summary

Study aim
Determining the effect of Del-Nido's cardioplegia solution returning to the extracorporeal circulation circuit on changes in serum osmolarity and clinical outcomes in children undergoing surgery for congenital heart disorders
Design
Clinical trial with control group, with parallel groups, single-blind, randomized, phase 3 on 38 patients. The block randomization method will be used to generate a sequence of random numbers
Settings and conduct
Department of Cardiac Surgery, Imam Reza Hospital, Mashhad, Iran.
Participants/Inclusion and exclusion criteria
Criteria for inclusion in the study: all children with a weight of 5 to 18 kg undergoing heart surgery for congenital defects with RACHS=1 and RACHS=2 and under CPB Exclusion criteria: lack of written parental consent to enter the study, presence of coagulation disorders before surgery, liver dysfunction with an increase in SGOT or SGPT more than 1.5 times the baseline level before surgery, presence of congenital kidney diseases, death Children during surgery, the need to perform complex surgery, children with RACHS score higher than 2, the occurrence of treatment-resistant fever after surgery, the occurrence of confirmed sepsis after surgery until the time of admission to the ICU, or the level of procalcitonin more than 0.5 ng/dC. L with symptoms of infection, CPB or transverse aortic clamp time more than 120 minutes
Intervention groups
In case group (A), the cardioplegia solution after suction is removed from the blood circulation circuit, and will be thrown away (waste). In the control group (B), the cardioplegia solution will enter the extracorporeal circulation after suctioning at the end of the surgery and will enter the systemic circulation of children through CPB.
Main outcome variables
Changes in serum osmolarity are investigated by considering serum levels of sodium, glucose and blood urea nitrogen.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240421061549N1
Registration date: 2024-06-09, 1403/03/20
Registration timing: registered_while_recruiting

Last update: 2024-06-09, 1403/03/20
Update count: 0
Registration date
2024-06-09, 1403/03/20
Registrant information
Name
Tahere Izanlou
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 938 403 7138
Email address
izanlout2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-04, 1403/03/15
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of return of Del-Nido cardioplegia solution to the extra-corporeal circulation circuit on serum osmolarity variations and clinical outcomes in pediatrics undergoing congenital cardiac defects surgery
Public title
The effect of return of Del-Nido cardioplegia solution to the extra-corporeal circulation circuit on serum osmolarity variations and clinical outcomes in pediatrics undergoing congenital cardiac defects surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All children with a weight of 5 to 18 kg undergoing heart surgery for congenital defects.
Exclusion criteria:
Absence of written parental consent to enter the study presence of coagulation disorders before surgery liver dysfunction with an increase in SGOT or SGPT more than 1.5 times the baseline level before surgery presence of congenital kidney diseases death of the child during surgery need To perform complex surgery children with RACHS score higher than 2 occurrence of fever resistant to treatment after surgery occurrence of confirmed sepsis after surgery until the time of admission to ICU procalcitonin level greater than 0.5 ng/dL with signs of infection CPB or transverse aortic clamp time more than 120 minutes.
Age
From 5 months old to 5 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 38
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the block randomization method will be used to generate a sequence of random numbers. In this method, 8 blocks of size 4 and 3 blocks of size 2 are randomly selected from the combination of letters A and B with a table of random numbers. The list of blocks with two sizes are 1: AB and 2: BA. The list of blocks with size four are: 1: AABB, 2: ABBA, 3: BBAA, 4: BAAB, 5: BABA, 6: ABAB. To select blocks of size 2, 3 numbers are randomly selected from the table of random numbers, then if this number is from 0 to 4, the first block is selected, and if the number is from 5 to 9, the second block is selected. To select blocks of size 4, 8 numbers between 1 and 6 are randomly selected from the table of random numbers, then if this number is 1, the first block is size 4, and if the selected number is 2, then the second block and so on for other blocks. are selected The generated allocation sequence is placed in sealed envelopes and will be reopened when the patients enter the plan.
Blinding (investigator's opinion)
Single blinded
Blinding description
Allocation Concealment method: The generated allocation sequence is placed in sealed envelopes and will be reopened when the patients enter the plan. On the day of the surgery, all patients were randomized by simple randomization method (Simple randomization) and based on the goal, into two groups: no return of cardioplegia solution to the extracorporeal circulation circuit (A), and return of cardioplegia solution to Extracorporeal circulation circuit (B) or, will be placed
Placebo
Not used
Assignment
Parallel
Other design features
Del-Nido cardioplegia solution will be used in both groups.Del-Nido Cardioplegia basic solution is one liter of plasmalite A solution, which is electrolyte-wise similar to extracellular fluid. whose basic composition includes 140 milliequivalents per liter of sodium, 5 milliequivalents per liter of potassium, 3 milliequivalents per liter of magnesium, 98 milliequivalents per liter of chloride, 27 milliequivalents per liter of acetate, 23 milliequivalents per liter It contains gluconate per liter and pH = 7.40. Due to the non-availability of plasmalite A solution in Iran, one liter of Ringer's serum is used. Cardioplegia additives that are added to one liter of plasmalite A include mannitol 20% in the amount of 16.3 ml, magnesium sulfate 50% in the amount of 4 ml, sodium bicarbonate 4.8% in the amount of 13 ml, potassium 15% chloride is 13.5 ml and 2% lidocaine is 13 ml. This cardioplegia is injected in a ratio of 1 to 4 of whole blood and crystalloid, after clamping the aorta in the root of the aorta, with an amount of 20 ml per kilogram of body weight in children, and if necessary, after 90 minutes, with an amount of half. The initial dose will be repeated. In the case group (A), the cardioplegia solution after suction will leave the blood circulation circuit, will not enter the systemic circulation and will be thrown away (Waste). In the control group (B) ), cardioplegia solution at the end of surgery, after suction, will enter the extracorporeal circulation and enter the systemic circulation of children through CPB.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
N0. 17 door plaque , No. 22 shahid ghollami , No. 130, Resalat Ave., North Resalat Blvd., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9149118341
Approval date
2024-02-05, 1402/11/16
Ethics committee reference number
IR.MUMS.IRH.REC.1402.22

Health conditions studied

1

Description of health condition studied
Congenital Heart Disease
ICD-10 code
Q20, Q21,
ICD-10 code description
Congenital malformations of cardiac chambers and connections

Primary outcomes

1

Description
Changes in serum osmolarity considering serum levels of sodium, glucose and blood urea nitrogen
Timepoint
- Serum glucose, blood urea nitrogen, and sodium levels of children will be measured and recorded before entering the operating room (T1), after entering the ICU (T2), and 24 hours after entering the ICU (T3). .- The serum creatinine level of children will be measured and recorded before entering the operating room (T1), after entering the ICU (T2), and 24 hours after entering the ICU (T3).
Method of measurement
Preparation of blood test samples at specified times

Secondary outcomes

1

Description
The time of separation from mechanical ventilation, the occurrence of neurological complications, the probable mortality index of children, the occurrence of acute renal failure (AKI)
Timepoint
Other patient information including: age, sex, weight, height, disease diagnosis, cardioplegia volume, aortic transverse clamp time, and cardiopulmonary bypass (CPB) time will be recorded.In case of dysrhythmia in children, the type of dysrhythmia will be recorded until admission to ICU.Postoperative morbidities including neurological complications, dysrhythmias, pulmonary congestion, pneumonia, and acute kidney injury will be recorded. Neurological complications include: Seizures, coma, brain edema or brain damage based on the data obtained from specialized imaging. Acute kidney injury is based on an increase of more than 50% in serum creatinine level or an increase in serum creatinine by 0.3 mg/dL will be defined as the baseline.The length of stay in the ICU will be recorded.Mortality of patients will be recorded in two groups.
Method of measurement
Heart and lung monitoring, blood test sample, Glasgow Coma level of consciousness scale, chest X-ray and CT scan or magnetic resonance imaging or MRI if needed.

Intervention groups

1

Description
Intervention group: In group (B), the Del-Nido cardioplegia solution will enter the extracorporeal circulation after suctioning at the end of surgery and will enter the systemic circulation of children through CPB cardiopulmonary bypass. Del-Nido cardioplegia solution will be used in both groups. Del-Nido cardioplegia base solution is one liter of plasmalite A solution, which is electrolyte-like as extracellular fluid, whose basic composition includes 140 milliequivalents per liter of sodium, 5 milliequivalents per liter of potassium, 3 milliequivalents per liter of magnesium, 98 milliequivalents per liter of chloride, 27 milliequivalents per liter of acetate, 23 milliequivalents per liter of gluconate and pH = 7.40 is Due to the non-availability of plasmalite A solution in Iran, one liter of Ringer's serum is used. Cardioplegia additives that are added to one liter of plasmalite A include mannitol 20% in the amount of 16.3 ml, magnesium sulfate 50% in the amount of 4 ml, sodium bicarbonate 4.8% in the amount of 13 ml, potassium 15% chloride is 13.5 ml and 2% lidocaine is 13 ml. This cardioplegia is injected in a ratio of 1 to 4 of whole blood and crystalloid, after clamping the aorta in the root of the aorta, with an amount of 20 ml per kilogram of body weight in children, and if necessary, after 90 minutes, with an amount of half The initial dose will be repeated.
Category
Treatment - Other

2

Description
Control group: group (A), the Del-Nido cardioplegia solution after suction is removed from the blood circulation circuit, will not enter the systemic blood circulation and will be thrown away (waste).
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mahmoud Hossein Zadeh
Street address
No. 17, 22 Shahid Gholami St.130 North Resalat Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9149118341
Phone
+98 938 403 7138
Email
izanlou3427@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaqodi
Street address
No. 17, 22 Shahid Gholami St.,130 North Resalat Blvd, Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9149118341
Phone
+98 938 403 7138
Email
izanlou3427@gmail.com
Web page address
https://research.mums.ac.ir/general/homePage.action
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahmoud Hossein Zadeh
Position
Master's student in blood circulation technology (perfusion)
Latest degree
Master
Other areas of specialty/work
Pediatric open heart surgery
Street address
No. 17, 22 Shahid Gholami St., 130 Resalat North Blvd , Mashhad city
City
Mashhad
Province
Razavi Khorasan
Postal code
9149118341
Phone
+98 938 403 7138
Email
izanlou3427@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahmoud Hossein Zadeh
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 17, 22 Shahid Gholami St., 130 Resalat North Blvd , Mashhad city
City
Mashhad
Province
Razavi Khorasan
Postal code
9149118341
Phone
+98 51 3273 7011
Email
izanlou3427@gmail.com
Web page address
https://research.mums.ac.ir/general/homePage.action

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahmoud Hossein Zadeh
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 17, 22 Shahid Gholami St., 130 Resalat North Blvd , Mashhad City
City
Mashhad
Province
Razavi Khorasan
Postal code
9149118341
Phone
+98 51 3273 7011
Email
izanlou3427@gmail.com
Web page address
https://research.mums.ac.ir/general/homePage.action

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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